There is a serious and fast growing worldwide problem related to abuse of prescription drugs. In particular, unauthorized persons may remove drugs, often addictive narcotics, from prescription bottles in the home or elsewhere such medications are found.
According to the Los Angeles Times, drug deaths now outnumber traffic fatalities in the United States. Recent analysis of government data has found drugs exceeded motor vehicle accidents as a cause of death in the United States, killing at least 37,485 people nationwide.
While most major causes of preventable death are declining, drugs are an exception. The death toll has doubled in the last decade, now claiming a life every 14 minutes. By contrast, traffic accidents have been dropping for decades because of huge investments in auto safety. Public health experts have used the comparison to draw attention to the nation's growing prescription drug problem, which they characterize as an epidemic.
Fueling the surge in deaths are prescription pain and anxiety drugs that are potent, highly addictive, and especially dangerous when combined with one another or with other drugs or alcohol. Among the most commonly abused are OxyContin, Vicodin, Xanax and Soma. One relative newcomer is fentanyl, a painkiller that comes in the form of patches and lollipops and can be about 100 times more powerful than morphine. Such drugs now cause more deaths than heroin and cocaine combined. See http://articles.latimes.com/2011/sep/17/local/la-me-drugs-epidemic-20110918.
The present invention relates to tamper evident devices and methods that do not restrict access by the authorized user to a medicine package or bottle containing pills or medication. For example, a combination lock restricts access if the authorized user forgets the combination. Likewise, a lock and key locks out the authorized user if the authorized user looses the key. Further, combination lock solutions allow any unauthorized user to try every possibility until finding the right combination.
The present invention records almost all illegitimate attempts to access a package or container utilizing the devices disclosed herein. Further, the present invention can be incorporated or used with almost any pill container or medicine package.
Some devices described as tamper-evident can be more correctly called tamper-resistant because they make a package more difficult to open for both the authorized user and the unauthorized user.
There are many types of containers on the market. Some of these are intended for medicines and the like. Because of the danger of an unauthorized person such as a child, or an unauthorized person seeking narcotics, taking a medicine, manufacturers have designed some bottle caps which are difficult to remove. However, this approach does not prevent the possibility of an unauthorized user opening the bottle and removing or tampering with the contents.
Some of these medicine bottles are claimed to be tamper-proof and achieve this alleged claim by having outer seals around the neck and cap. Some containers claim to be are tamper-evident. These are often quite complicated or bulky.
One such container is shown in Hoag, U.S. Pat. No. 4,426,004, which discloses a tamper-evident container that completely encloses a medicine bottle. Two box-like portions are connected by frangible portions. To access the bottle, the box-like portions are broken apart. Colella, U.S. Pat. No. 3,820,654, discloses a safety container which uses a key to open the container. Walker, U.S. Pat. No. 4,778,070, discloses a tamper-evident bottle cap having frangible pins.
Many of the drugs abused are narcotic pain killers. Thus, patients suffering from severe pain have little tolerance for a package that is difficult to open or has a locking mechanism as discussed above.
Many people take one or more medications, several times a day to maintain or improve their health. Often, these medications or supplements must be taken at specific times each day. If medications or supplements are not available to be taken at the proper times, individual health may be jeopardized.
For example, failure to take a prescribed medication for treatment of chronic pain can result in severe health consequences such as severe pain or withdrawal.
Non-compliance with a prescribed regimen of one or more medications, particularly in the elderly and the aging population of “baby boomers”, can result in billions of dollars of unnecessary health care costs.
Further, it can be extremely difficult to monitor tampering with multiple medication schedules. Failure to properly monitor tampering can result in catastrophic health consequences to the patient and high levels of care taker anxiety, which can also lead to increased health problems for care takers.
Known medicine tamper-evident systems have severe limitations. One such limitation is that the authorized user may be prevented from taking their medicine. Another such limitation is the inability for an authorized user or a care taker to track whether someone other than the authorized user is taking medication.
The present invention solves these difficult problems in a novel manner. As such, this invention makes it more difficult for prescription drug abusers to take medicine from family members or other persons without being detected.
Novel tamper evident devices and methods for monitoring and improving authorized users' knowledge of tampering are disclosed herein.